510(k) · Cleared
ClearedPhlebotomy Sharps Disposal Containers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sage Products, Inc. · MMK Container, Sharps
Cleared on Mar 22, 1995 after a 238-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Mar 22, 1995
- Review
- 238 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK943660 Phlebotomy Sharps Disposal ContainersSage Products, Inc. · 1995
- Descendant · cites it directly · 7 of its ownK130281 Oak Ridge Products Sharp ContainerOak Ridge Products, LLC · 2013
- Descendant · 2 generations on · 3 of its ownK161180 Oak Ridge Products Sharps ContainersOak Ridge Products, LLC · 2016
- Descendant · 3 generations on · 2 of its ownK180984 Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019
- Descendant · 4 generations on · 0 of its ownK253773 Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container…Taizhou Huangyan Guanhong Plastic Steel Products Factory · 2026
- Descendant · 4 generations on · 0 of its ownK253222 Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K130281Oak Ridge Products Sharp ContainerOak Ridge Products, LLC · 2013 · cites it directly7descendants
- K161180Oak Ridge Products Sharps ContainersOak Ridge Products, LLC · 2016 · 2 generations on3descendants
- K180984Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019 · 3 generations on2descendants
- K253773Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong…Taizhou Huangyan Guanhong Plastic Steel Products Factory · 2026 · 4 generations on0descendants
- K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943660 | Phlebotomy Sharps Disposal Containers | Sage Products, Inc. | 1995 | — |
| +1 | K130281 | Oak Ridge Products Sharp Container | Oak Ridge Products, LLC | 2013 | — |
| +2 | K161180 | Oak Ridge Products Sharps Containers | Oak Ridge Products, LLC | 2016 | — |
| +3 | K180984 | Maxcon Sharps Container | Ningbo Maxcon Medical Technology Co., Ltd. | 2019 | — |
| +4 | K253773 | Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4)… | Taizhou Huangyan Guanhong Plastic Steel Products Factory | 2026 | — |
| +4 | K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Zhejiang Gongdong Medical Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MMK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MMK device
- #1 K253773 Guanhong Sharps Container (GHW-1F1); Guanhong…score 12.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130281 | Oak Ridge Products Sharp Container | 2013 | 7 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K130281 (Oak Ridge Products, LLC, 2013) has gone furthest, with 7 descendants of its own.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MMK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMK
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMK
No recall names MMK since 2007.
Adverse event reports per year · MMK
5in 2025
MAUDE reports naming product code MMK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 63 | 0 | 5 |
| 2008 | 6 | 61 | 0 | 21 |
| 2009 | 4 | 100 | 0 | 9 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 2 | — | 0 | 16 |
| 2013 | 5 | 136 | 0 | 20 |
| 2014 | 6 | 210 | 0 | 13 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 4 | 258 | 0 | 27 |
| 2017 | 1 | — | 0 | 39 |
| 2018 | 1 | — | 0 | 63 |
| 2019 | 4 | 265 | 0 | 56 |
| 2020 | 1 | — | 0 | 62 |
| 2021 | 3 | 149 | 0 | 85 |
| 2022 | 1 | — | 0 | 38 |
| 2023 | 3 | 251 | 0 | 34 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 3 | 84 | 0 | 5 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K943660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943660: Phlebotomy Sharps Disposal Containers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943660
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026